1214578
Control-X Medical Zrt. — FEI 3012093201
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 10, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Budapest (Hungary)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3671 | 21 CFR 820.25(a) | Personnel |